Pursuant to your request for voluntary withdrawal dated January 13, 2009, regarding the above referenced Premarket Notification (510(k)) submission by the U.S. Department of Defense, the Office of Blood Research and Review acknowledges your letter and rescinds its determination of substantial equivalence of August 1, 1997, for the above referenced device. This specific device, submitted under BK960004, can no longer be marketed in the United States without a new order allowing you to do so. In addition, it can not serve as a predicate device for purposes of determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, for any other devices that may be submitted for review or are currently under review for a determination of substantial equivalence.

If you have any questions regarding this letter, please contact Heather Erdman, Regulatory Project Manager, at (301) 827-6182.

Sincerely yours,

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Jay S. Epstein, M.D. Director Office of Blood Research and Review Center for Biologics Evaluation and Research